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Implant Classical Esthetic D5.3mm L6mm
EUDAMEDClass IIb (EU MDR)
Ref 1046Model ICE
Identity
- Trade Name
- Implant Classical Esthetic D5.3mm L6mm EUDAMED
- Model / Reference
- ICE EUDAMED1046 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290117811900 EUDAMED
- Basic UDI-DI
- 729011781ICEJ6 EUDAMED
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Implant Classical Esthetic D5.3mm L6mm by Alpha Bio Tec Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 729011781ICEJ6 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Alpha Bio Tec Ltd.
- EUDAMED SRN
- IL-MF-000021145
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED 73e7221f-7ae1-41f0-b393-a7247367bd07 61 fields · synced Sep 18, 2026